TSI and Its Relationship With Graves' Disease Relapse

Completed

• Conditions: Graves Disease; Anti-Thyroid Antibodies Disorder; Immunoglobulin
• Interventions: Diagnostic Test: TSI

• Registration Number: NCT05713097
• Lead Sponsor: University of Medicine and Pharmacy at Ho Chi Minh City

Brief Summary

The goal of this observational study is to determine the role of TSI, as well as clinical signs and thyroid function tests in predicting Graves' disease (GD) relapse after withdrawing anti thyroid drug (ATD). The main questions it aims to answer are:

1. To investigate the serum TSI concentration in patients with GD undergoing maintenance-dose ATD.

2. To determine an optimal cut-off of TSI level for predicting GD relapse.

3. To determine the role of TSI in predicting Graves' disease relapse after withdrawing ATD.

Detailed Description

Retrospective follow-up study of patients with hyperthyroidism due to Graves' disease, treated at the endocrine outpatient clinic of Medic Medical Center, Ho Chi Minh City from January 2000 to April 2021. TSI was measured several times during the course of treatment when planning to stop medication (at the discretion of the attending physician). ATD withdrawal would be planned when patients achieved euthyroid status clinically with normal FT4 tests for at least 3 months with minimal dose of ATD. The decision was also based on TSI concentration, goiter's characteristics and parenchymal vascularity on Doppler ultrasound.

Study Timeline

• Study Start: 2022-01-02
• Primary Completion: 2022-08-31
• Study Completion: 2022-08-31
• Study First Submitted: 2023-01-13
• Status Verified: 2023-02
• Study First Submitted QC: 2023-02-02
• Last Update Submitted: 2023-02-02
• Study First Posted: 2023-02-06
• Last Update Posted: 2023-02-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 352

Inclusion Criteria

• Patients diagnosed with hyperthyroidism due to Graves' disease according to the criteria of the Japan Thyroid Association.
• TSI: measured during the course of treatment when planning to stop medication (normal FT4 at maintenance-dose of ATD) Methimazole (MMI): at doses of ≤10 mg. Propylthiouracil (PTU): at doses of ≤200 mg.

Exclusion Criteria

• Hyperthyroidism due to other causes
• Patients who were intolerant to ATD or had serious side effects with ATD.
• TSIs were measured in pregnancy.
• Patients treated with surgery or radioactive iodine.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
No ATD withdrawal	TSI	Patients treated with ATD still the end of the study
ATD withdrawal	TSI	ATD treatment was decided to be stopped at the discretion of the attending physician. Then, patients were followed after ATD withdrawal to determine who would have relapse of GD. Finally, patients were divided into 2 groups: Relapse and No relapse

Primary Outcome Measures

Name	Time	Method
Number of Participants with GD relapse	at least 1 year after ATD withdrawal	Patients who had relapse of hyperthyroidism due to GD

Secondary Outcome Measures

Name	Time	Method
TSI LEVEL IN PATIENTS WITH GRAVES' DISEASE UNDERGOING MAINTENANCE-DOSE OF ANTITHYROID DRUG.	before ATD withdrawal	TSI level before planning for ATD withdrawal
Optimal cut-off of TSI level for predicting GD relapse	before ATD withdrawal	Optimal cut-off of TSI level before ATD withdrawal for predicting GD relapse

Trial Locations

Locations (1)

Hoa Hao Clinic; 🇻🇳 Ho Chi Minh City, Vietnam